Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K211442
Device Name StealthStation Spinous Process Clamps
Applicant
Medtronic Navigation
826 Coal Creek Cir.
Louisville,  CO  80027
Applicant Contact Victoria Baldock
Correspondent
Medtronic Navigation
826 Coal Creek Cir.
Louisville,  CO  80027
Correspondent Contact Victoria Baldock
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/10/2021
Decision Date 07/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-